Transcranial magnetic stimulation system and methods

ABSTRACT

A transcranial magnetic stimulation device in accordance with embodiments of the present invention comprises a head mount for disposition on a head of a patient and configured with a plurality of attachment points, a plurality of magnetic assembly devices connected to the plurality of attachment points, a given magnetic assembly device equipped with an actuator device to actuate a magnet, is addressable, and configured to receive a control signal addressed to the given magnetic assembly device, and a processor having a memory and configured by program code. The processor is configured to: select one or more treatment protocol units, generate a control signal using at least information contained in the selected treatment protocol units, energize at least one magnetic assembly device over a period of time to cause the magnet to actuate according to the control signal, and monitor the patient response to energizing to addressable actuator.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

This is a Continuation of U.S. application Ser. No. 15/243,669, filedAug. 22, 2016 and claims the benefit of priority under 35 U.S.C. Section119(e) of U.S. Application Ser. No. 62/355,209, filed Jun. 27, 2016,which are hereby incorporated by reference in their respectiveentireties.

FIELD OF THE INVENTION

The present invention is directed to systems that implement TranscranialMagnetic Stimulation and methods of use thereof. In particular,embodiments of the invention relate to energizing one or more magneticassembly devices, which may comprise energizing sets of magneticassembly devices in parallel or serial, that are in proximity of thecranium of a patient such that energizing causes the generation of anelectrical field within the brain of the patient. A treatment protocolunit comprises program code that identifies a plurality of operatingparameters of a given magnetic assembly device and, when interpreted bya programmable processor, instruct the processor as to manner and timingof such energizing. A plurality of treatment protocol units can begrouped for processing and stored as a treatment protocol to allow forthe reproducible treatment of a given illness.

BACKGROUND OF THE INVENTION

Transcranial Magnetic Stimulation (“TMS”) is a non-invasive procedure inwhich magnetic stimulation is applied to the brain to modify the naturalelectrical activity of the brain, to provide therapy to a patient, toassist in diagnosis, to map out brain function in neuroscience researchor implement any other technique where it might be advantageous tomodify the natural electrical activity of the brain. More particularly,certain TMS techniques apply a rapidly changing magnetic field to thebrain of a patient to induce weak electric currents in the brain of thepatient by way of electromagnetic induction. TMS has been approved bythe U.S. Food and Drug Administration (“FDA”) for treating depression.TMS is also currently being investigated in the management of variousother neurological and psychiatric disorders including, but not limitedto, migraines, aphasia, anxiety, Parkinson's disease, tinnitus, autism,schizophrenia, Alzheimer's, ALS, stroke (e.g., ischemic), MyotonicDystrophy type 1 (“DM1”), stuttering, epilepsy, visceral pain anddystonia, as well as cocaine, opioid and other addictive behavior.

Researchers in the field of TMS are increasingly uncovering ailments andconditions that can be managed or ameliorated through the use of TMSdevices. For example, the following non-exhaustive list of scholarlyliterature details the use of TMS to treat various ailments, all ofwhich are hereby incorporated by reference as it set forth in itsentirety herein:

-   -   Rosenfield, David, et al., “Neuromodulation by Paired        Associative Brain Magnetic Stimulation of Speech Areas in        Stuttering”, MORTI—Methodist Online Research Technology        Initiative, Date Entered State: Feb. 12, 2015;    -   Simpson, Ericka, et al., “A pilot study of repetitive multisite        transcranial magnetic stimulation with wearable device in        Myotonic Dystrophy type 1”, MORTI—Methodist Online Research        Technology Initiative, Date Entered State: Nov. 10, 2014;    -   Appel, Stanley, et al., “Focal Magnetic Stimulation of the Motor        Cortex to Induce Motor Evoked Potentials for Diagnostic        Evaluation in Amyotrophic Lateral Sclerosis”, MORTI—Methodist        Online Research Technology Initiative, Date Entered State: Sep.        30, 2013;    -   Appel, Stanley, et al., “Focal Magnetic Stimulation of the Motor        Cortex to Induce Motor-Evoked Potentials for Diagnostic        Evaluation in Amyotrophic Lateral Sclerosis”, MORTI—The        Methodist Hospital Research Institute, Study Approval: Sep. 24,        2015;    -   Chiu, David, et al., “Multifocal brain magnetic stimulation in        chronic ischemic stroke. An Innovative Approach to Restoration        of Function in Chronic Ischemic Stroke using a New Wearable        Multifocal Brain Stimulator”, MORTI—Methodist Online Research        Technology Initiative, Date Entered State: Apr. 20, 2016; and    -   Chiu, David, et al., “An Innovative Approach to Restoration of        Function in Chronic Ischemic Stroke using a New Wearable        Multifocal Brain Stimulator”, MORTI—Methodist Online Research        Technology Initiative, Consent Approval Date: Mar. 30, 2016.

Furthermore, Theta Burst Stimulation (TBS), a high-frequency variant ofTMS has been shown to induce prolonged plasticity changes in the brain.The induction of plasticity-like effects by TBS is useful in bothexperimental and therapeutic settings.

U.S. patent application Ser. No. 13/829,349, published as U.S. PatentPublication No. 2014/0276182, hereby incorporated by reference as if setforth in its entirety herein, describes TMS apparatus as generallycomprising an electromagnetic coil that is in a fixed position relativeto the head of the patient. Since the magnetic field applied to thepatient is a function of the configuration of the electromagnetic coil,the current passed through the electromagnetic coil, and the location ofthe electromagnetic coil relative to the patient, the fixed constructionof such a TMS apparatus significantly limits the character of themagnetic field that can be applied to the patient, and, accordingly, theTMS therapies that can be provided to the patient. In addition, such TMSapparatuses generally utilize very high electrical currents in theelectromagnetic coil, which raises the risk of accidental injury to thepatient through electric shocks, burns, seizures, etc.

In the art there exists a need to have both standardized andcustomizable libraries of patterns of magnetically induced currentwithin the brain of a patient for particular treatments. Currentlyavailable TMS devices generally follow set routines for determiningwhich of a plurality of magnets arranged on a cap or helmet are used toinduce electric fields. Determining which magnet or magnets to use toinduce electric fields, as well as the corresponding operationalparameters, is often left to researchers or practitioners. Thus,reproducible and improved results are only achievable by codifying thevarious operational parameters that influence the electric fieldsinduced in the brain of a user as part of any given therapy.

What is therefore needed in the art are systems, methods and computerprogram products for inducing electric currents within the brain of asubject using TMS treatments while minimizing the potential for negativeside effects due to high current electromagnets. Furthermore, what isneeded is a library of standardized and customizable treatment protocolunits that can be used to build a treatment protocol that iscustomizable to the specific user, ailment, diagnostic technique orvarious combinations thereof.

SUMMARY OF THE INVENTION

Embodiments of the invention are directed towards systems, methods andcomputer program products for transcranial magnetic stimulation systemusing magnetic assembly devices that variably energize and, whenenergized, create one or more electrical fields within the brain of apatient. In one embodiment, the present invention is directed to atranscranial magnetic stimulation system comprising a plurality ofaddressable magnetic assembly devices each connected to a respectiveplurality of attachment points on a cap intended to be worn on the headof a patient. A given magnetic assembly device is equipped with anactuator device to actuate a magnet, which may comprise rotation of apermanent magnet, the actuation device configured in certain embodimentsto rotate the magnet at one of a plurality of frequencies.

A given one of the magnetic assembly devices is configured to receive acontrol signal addressed to the actuator and monitor, through one ormore sensors, one or more operating parameters associated with the agiven magnetic assembly device. Furthermore, the system utilizes aprocessor having a memory and being configured by code executed therebyto: select at least one treatment protocol unit for inclusion in atreatment protocol that applies a therapeutic or diagnostic treatment,wherein a given treatment protocol unit comprises at least datacorresponding to a rotational frequency; generate a control signal usingat least information contained in the selected treatment protocol unitsand energize at least one magnetic device assembly over a period of timeto rotate according to the control signal. The program code furtherinstructs the processor as to monitoring the patient in response toapplication of a given treatment protocol unit.

In another embodiment, the present invention is directed to a method fortranscranial magnetic stimulation that comprises providing a head mountfor disposition on the head of a patient. The head mount comprises aplurality of points for releasable mounting a plurality of magneticdevice assemblies, a given magnetic device assembly comprising a magnetand an actuator device for selectively providing a rapidly changingmagnetic field capable of inducing weak electric currents in the brainof a patient so as to apply a treatment that modifies the naturalelectrical activity of the brain of the patient. The head mount ispositioned on the head of the patient in conjunction with a selectednumber of magnet assemblies supported on the head mount at selectedlocations. The method continues with the selection of one or moretreatment protocol units for assembly into a treatment protocol forexecution by a programmable processor, the programmable processoroperative to generate one or more control signals for respectivemagnetic device assemblies on the basis of the treatment protocol units.A rapidly changing magnetic field is provided by at least one of themagnet assemblies in accordance with the treatment protocol and inresponse to receipt of a respective control signal.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the invention are illustrated in the figures of theaccompanying drawings which are meant to be exemplary and not limiting,in which like references are intended to refer to like or correspondingparts, and in which:

FIG. 1 illustrates a block diagram of a system for transcranial magneticstimulation according to one embodiment of the present invention;

FIG. 2 presents a block diagram illustrating a magnetic assembly deviceaccording to one embodiment of the present invention;

FIG. 3 presents a block diagram illustrating a persistent data storemaintaining a set of treatment protocol units according to oneembodiment of the present invention;

FIG. 4A presents a block diagram illustrating a treatment protocol thatcomprises multiple treatment protocol units in accordance with oneembodiment of the present invention;

FIG. 4B presents a block diagram illustrating a treatment protocol thatcomprises multiple treatment protocol units in accordance with analternative arrangement as compared to that of FIG. 4A;

FIG. 5 presents a flow diagram illustrating a process for creating ormodifying a treatment protocol unit in accordance with one embodiment ofthe present invention;

FIG. 6 presents a flow diagram illustrating a process for the creationof a new treatment protocol in accordance with one embodiment of thepresent invention;

FIG. 7 presents a flow diagram illustrating a process for editing anexisting treatment protocol in accordance with one embodiment of thepresent invention; and

FIG. 8 presents a flow diagram illustrating a process for executing atranscranial magnetic stimulation treatment protocol on a patient inaccordance with one embodiment of the present invention.

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS OF THE INVENTION

By way of overview, various embodiments of the systems, methods andcomputer program products described herein are directed towards atranscranial magnetic stimulation device that is configurable throughthe use of one or more treatment protocol units that an operator orsoftware process selects from a library of treatment protocol units. Acollection of one or more treatment protocol units define a treatmentprotocol for execution by a programmable processor as a set of computerprogram instructions, which causes one or more actuator devices torotate one or more magnets to induce varying electric fields within thebrain of the patient. As used herein, a patient is any person thatinteracts with the transcranial magnetic stimulation device, eitherthrough operation or application, and which may include at leastinteraction for diagnostic, therapeutic or mapping purposes. A patientself-directing the system described is referred to as a patient or,alternatively, as a user. Likewise, a person directing the system wornby another is also indicated as a user or a clinician, as used herein.

With particular reference to FIG. 1, the transcranial magnetic systemcomprises a harness, frame or cap 102 that may be secured to the head ofa patient (not shown). The cap 102 is configured with a plurality ofattachment points where one or more magnetic assembly devices 104 can bepermanently connected. Alternatively, or in conjunction with theforegoing, one or more magnetic assembly devices 104 may be detachablyaffixed to the cap 102. In one configuration, therefore, attachmentpoints may be predetermined, such as through the use of snaps, buttons,fasteners or other fixed attachment points that permit the releasableattachment of the magnetic assembly devices 102 to the cap at specificpoints thereon. Instead of or in conjunction with the foregoing, the capcan be equipped with rails, channels or similar structures containingconductive elements that enable a given magnetic assembly device 104 tobe variably secured at any point along the channel or rail, depending onthe desired treatment location or the cranial structure of a givenpatient. The attachment points can all be of like design to permit astandard magnetic assembly device to be attached anywhere along the cap102, or the attachment points can provide more than one fitting to matewith particular, corresponding magnetic assembly devices.

In accordance with the embodiment that FIG. 1 illustrates, theattachment points are positioned on the cap 102 at locationscorresponding to specific areas of the brain of a given user, therebyoptimizing the delivery of magnetic energy for a given diagnosis,therapy, mapping, or other application of the present invention. It willbe appreciated by those possessing an ordinary level of skill in therequisite art, however, that other configurations of the magneticassembly devices 104 are possible on the basis of the underlingapplication or desired result.

A given magnetic assembly device 104 that may be affixed to the cap 102comprises an actuator device (not shown) and a magnet 105. FIG. 2provides a more detailed illustration of an exemplary magnetic assemblydevice 104 (now labeled 202, but in all respects can be the same device)in which the actuator device 204 is a motor configured to rotate amagnet 206 in response to control signals that the actuator device 204receives via a controller 210. In one or more configurations, theactuator device 204 is a stepper motor. In an alternative arrangement,however, the actuator device 204 is a brushed motor. Other actuatordevice types known to those of skill in the art can further be utilizedby certain embodiments. In accordance with various embodiments of themagnetic assembly device 202 shown in FIG. 2, the actuator device 204 isa variable speed motor, such that the magnet 206 may be rotated fasteror slower as desired or needed by a given treatment protocol, which isexplained in greater detail herein.

In accordance with various embodiments of the system of the presentinvention, a number of disparate types of magnets may be used. In oneembodiment of the magnetic assembly device 202, the magnet 206 is anelectromagnet. In alternative embodiments, however, the magnet is apermanent magnet. In accordance with a system utilizing one or morepermanent magnets, such permanent magnet is a rare earth, or naturalmagnet, e.g., a neodymium magnet. In an alternative arrangement, themagnet 206 is a soft magnetic composite (“SMC”) magnet.

The magnet 206 is affixed to a rotator shaft 208 in communication withthe actuator device 204, such that when the actuator device 204 isenergized, the magnet 206 rotates about an axis. Rotating the magnet 206creates a rapidly changing magnetic field about the magnetic assemblydevice 202. In one embodiment of the invention, each of the magnetassembly devices comprises a permanent magnet for selectively providinga rapidly changing magnetic field of at least 500-600 Tesla/second andcorresponding to a magnet movement speed of no less than 400 Hertz. Aswill be appreciated by those knowledgeable in the field of TMS, weakelectric current is induced in neurons within the brain of a patientthrough the application of a rapidly changing magnetic field of at least500-600 Tesla/second and corresponding to magnet movement speed of noless than 400 Hertz. These weak electric currents modify the naturalelectrical activity of the brain of the patient to provide the patientwith targeted therapies, to assist in diagnosis or to map out brainfunction for use in neuroscience research.

In one exemplary configuration of the magnetic assembly device 202, theactuator device 204 may comprise both a motor for rotating the magnetand a lateral movement device (not pictured) for changing the positionof the magnet relative to the patient, such as solenoid. In thisexemplary configuration, the lateral movement device in the magneticassembly device 202 positions the magnet 206 closer or further away frombrain of the patient, which may be dependent upon particular treatmentparameters that a user is applying to the patient. The lateral movementdevice optionally enables azimuth adjustment in addition to or as thelateral movement.

In a further arrangement, the magnetic assembly device 202 comprises oneor more sensors 212 used to monitor the magnetic field, temperature ofthe assembly device, the current induced in the brain, or other datapoints regarding the patient that the sensor may collect. Such data cancomprise biophysical data as is known to those of skill in the art. Inone arrangement, the sensors 212 comprise an array of one or moreelectrodes that are configured to measure electrical activity of thebrain and send the measured data as a signal back to the controller 210.

As the embodiment of FIG. 2 illustrates, one or more sensors 212deployed as part of the magnetic assembly device 202 collect informationwith respect to the operational conditions of the device 202, such asmeasuring magnetic fields, current induced and temperature. Thesensor(s) 212 can pass the gathered information back to the controldevice via a return channel from the magnetic assembly device 202 to thecontroller 210. According to one embodiment, the sensor(s) 212 pass thegathered information back to the control device in real-time. In thisembodiment, the processor at the control device receives the operationalparameters from the sensor(s) 212 and activates or deactivates one ormore of the magnetic assembly devices 202, e.g., upon detection ofconditions that exceed safety or comfort thresholds, or in response tofeedback regarding desired output levels.

The data gathered can be packaged and uploaded to a persistent datastore, which may be local or remote to the control device, e.g., toserve as supporting data with regard to the safety or efficacy of aparticular treatment protocol unit or treatment protocol. The collectedinformation on the efficacy of a particular treatment protocol orindividual treatment protocol units can be collected and sent to apersistent data store for access and evaluation by third parties. Forexample, researchers accessing such collected information are thus ableto test and validate individual treatment protocol units and treatmentprotocols, both of which are described in detail herein, as well as makealterations or modifications thereto. Such modifications can be directedto improvements in treating a particular ailment or repurposing atreatment protocol unit or treatment protocol to address a differentailment or condition.

Turning back to the exemplary embodiment that system that FIG. 1illustrates, a given one of the magnetic assembly devices 104 may bedirectly connected to the control device 106. In accordance with oneembodiment, a given one of the magnetic assembly devices 104 isconnected to a controller 108 that is part of the control device 106,which can be the same as controller 210 mentioned above. The controller108 is under the direction and control of a processor 112 that instructsthe controller 108 to selectively deliver control signals to one or moreof the magnetic assembly devices 104, thereby causing the magnet 105that forms a component of a given magnetic assembly device 104 torotate. As is described in greater detail herein, rotation of magnet 105by an actuator device is effected by the controller 108 in accordancewith the specific instructions that the controller 108 receives from theprocessor 112.

The controller 108 communicates with one or more of the magneticassembly devices 104 through a physical link, a wireless link orcombinations thereof. As shown in exemplary embodiment of FIG. 1, thecontroller communicates with the magnetic assembly devices 104 usingsingle communication links, one for each magnetic assembly device 104.In certain configurations, however, the controller 108 communicates withthe magnetic assembly devices 104 through the use of variouscombinations of one or more conduits, USB, serial, or wired or wirelesscommunication links that are known to those of ordinary skill in theart.

In the provided example, the controller 108 may comprise a discreteprocessor, gate array, logic switch or other device configurable toselectively energize one or more magnet assembly devices 104 in responseto an instruction set or command signal, which the control device 106may receive from an operator or automated software process. Forinstance, the controller 108 may be a processor configured with hardwareand/or software switches to control the activation state and rotation ofthe magnetic assembly devices 104, access activation state dataregarding of one or more connected magnetic assembly devices, as well asprovide additional instructions to and collect any incoming data from agiven magnetic assembly device 104. The controller 108 comprises one ormore mechanisms, such as specified or listed ports, for identifying andselecting one or more specific magnetic assembly devices 104.Accordingly, since connections between the controller 108 and themagnetic assembly device 104 are known and identified, the controldevice 106 provides for individual control of specific magnetic assemblydevices 104.

Where a controller 108 is present and connected to the magnetic assemblydevices 104, the activation of one or more of the magnetic assemblydevices 104 are operated in response to a set of one or more controlinstructions or signals passed by the controller 104 from a computer orprocessor 112. In one implementation, the controller 108 has a physicalconnection to the processor 106. In an alternative configuration wherebythe processor 112 is housed in a device or assembly that is external tothe controller 108, the controller 108 and processor 112 are equippedwith bi-directional communication hardware and software protocols toallow for data to be exchanged by and between the controller 108 and theprocessor 112.

The control device 106 according to one embodiment of the presentinvention is a desktop or workstation class computer that executes acommercially available operating system, e.g., MICROSOFT WINDOWS, APPLEOSX, UNIX or Linux based operating system implementations. In accordancewith further embodiments, the control device 106 is a portable computingdevice such as a smartphone, wearable or tablet class device. Forexample, the control 106 is an APPLE IPAD/IPHONE mobile device, ANDROIDmobile device or other commercially available mobile electronic deviceconfigured to carry out the processes described herein. In otherembodiments, the control device 106 comprises custom or non-standardhardware configurations. For instance, the control device 106 maycomprise one or more micro-computer(s) operating alone or in concertwithin a collection of such devices, network adaptors and interfaces(s)operating in a distributed, but cooperative, manner, or array of othermicro-computing elements, computer-on-chip(s), prototyping devices,“hobby” computing elements, home entertainment consoles and/or otherhardware.

The control device 106 can be equipped or is in communication with apersistent storage device 118 that is operative to store the operatingsystem in addition to one or more of software modules 122, such as thosedescribed herein to implement transcranial magnetic stimulation inaccordance with embodiments of the present invention. In one embodimentof the present invention, the modules utilized by the control device 106comprise software program code 122 and data 120 that are executed orotherwise used by the processor 112 comprising the control device 106(e.g., executed code), thereby causing the control device 106 to performvarious actions dictated by the software code of the various modules122. In accordance with certain embodiments, the control device 106 isin communication with a persistent data store 118 that is located remotefrom the control device 106 such that the control device 106 access theremote persistent data store over a computer network, e.g., theInternet, via a network interface 110, which implements communicationframeworks and protocols that are well known to those of skill in theart.

In addition to a persistent storage device 118, the control device 106may comprise primary computer memories, such as a read only memory (ROM)116 and/or a random access memory (e.g., a RAM) 114. The computermemories may also comprise secondary computer memory, such as magneticor optical disk drives or flash memory, that provide long term storageof data in a manner similar to the persistent storage device 118. Inaccordance with one or more embodiments, the memory comprises one ormore volatile and non-volatile memories, such as Programmable ReadOnly-Memory (“PROM”), Erasable Programmable Read-Only Memory (“EPROM”),Electrically Erasable Programmable Read-Only Memory (“EEPROM”), PhaseChange Memory (“PCM”), Single In-line Memory (“SIMM”), Dual In-lineMemory (“DIMM”) or other memory types. Such memories can be fixed orremovable, as is known to those of ordinary skill in the art, such asthrough the use of removable media cards or similar hardware modules. Inone or more embodiments, the memory of the control device 106 providesfor storage of application program and data files when needed by theprocessor 112. One or more read-only memories 116 provide program codethat the processor 112 reads and implements at startup orinitialization, which may instruct the processor 112 as to specificprogram code from the persistent storage device 118 to load into RAM 114at startup.

Certain embodiments contemplate deploying the persistent data store 118as a database that is connected to the control device 106 and containsat least transcranial magnetic stimulation application program code 122and a library of treatment protocol units 120 for execution by theprocessor 112 in governing the operational parameters of the magneticassembly devices 102. The treatment protocol units are, in onearrangement, data objects detailing specific operational characteristicsthat are implementable by the magnetic assembly devices 104. As isdescribed in greater detail herein, one or more treatment protocol unitsmay be sequentially combined to form a treatment protocol.

In one configuration, the database 118 is connected to the controldevice 106 via a server or network interface 110 and provides additionalstorage or access to user data, community data, or general purpose filesor information. The physical structure of the database 118 may beembodied as solid-state memory (e.g., ROM), hard disk drive systems,RAID, disk arrays, storage area networks (“SAN”), network attachedstorage (“NAS”) and/or any other suitable system for storing computerdata. In addition, the database 118 may comprise caches, includingdatabase caches and/or web caches. Programmatically, the database 118may comprise flat-file data store, a relational database, anobject-oriented database, a hybrid relational-object database, akey-value data store such as HADOOP or MONGODB, in addition to othersystems for the structure and retrieval of data that are well known tothose of skill in the art.

Building on the prior example, the control device 106 at startupretrieves initial instructions from ROM 116 as to initialization of theprocessor 112. Upon initialization, program code that the processor 112retrieves and executes from ROM 116 instructs the processor to retrieveand begin execution of transcranial magnetic stimulation applicationprogram code 122. The processor begins execution of the transcranialmagnetic stimulation application program code 122, loading appropriateprogram code to run into RAM 114 and presents a user interface to theuser that provides access to one or more functions that the program code122 offers. According to one embodiment, the transcranial magneticstimulation application program code 122 presents a main menu afterinitialization that allows for the creation or modification of treatmentprotocol units and treatment protocols, as well as the application orone or more treatment protocols to a user. While reference is made tocode executing in the processor, it should be understood that the codecan be executed or interpreted or comprise scripts that are used by theprocessor to implement prescribed routines.

When a user desires to create one or more treatment protocol units, heor she may access functionality that the transcranial magneticstimulation application program code 122 provides to instantiate a datastructure that represents such treatment protocol units 120. As isdescribed in greater detail herein, the operational parameters of agiven treatment protocol unit 120 comprise a series of key-value pairsthat user defines and which control operation of one or more magneticassembly devices. Similarly, when the user desires to modify one or moretreatment protocol units 120, he or she may access functionality thatthe transcranial magnetic stimulation application program code 122provides to browse, select and edit a data structure that represents atreatment protocol unit 120. More generally, a treatment protocol unit120 defines the manner in which one (and more typically at least two) ormore magnetic assembly devices 104 are energized to create electricfields across various areas of the brain of a patient over a window oftime. Such information is used by the transcranial magnetic stimulationapplication program code 122 to instruct the processor as to the mannerin which to energize, via the controller 108, the set of magneticassembly devices 104 to create such a field.

The one or more treatment protocol units 120 that the processor 112executes under control of the transcranial magnetic stimulationapplication program code 122 provide commands to the controller 108 asto the manner in which it should instruct individual magnetic assemblydevices 104 to rotate. Receipt of such signals from the controller 108by a given magnetic assembly device 104 causes its actuator to rotateits associated magnet at a particular frequency for a particularduration. Such rotation of the magnet at a set frequency results in thegeneration of a desired electric field within the brain, which may beused as part of a therapy, diagnosis, mapping or other medicaldiagnostic treatment.

Advantageously, the transcranial magnetic stimulation applicationprogram code 122 allows the user to select sets of treatment protocolunits to form one or more treatment protocols. Through the use of a userinterface that the transcranial magnetic stimulation application programcode 122 provides, which may be a GUI or text based interface, the usercan define a set of treatment protocol units that the processor appliesto the patient as a set treatment protocol. According to one embodiment,the transcranial magnetic stimulation application program code 122serially applies the treatment protocol units comprising a treatmentprotocol. Alternatively, the transcranial magnetic stimulationapplication program code 122 may dynamically arrange and apply thetreatment protocol units comprising a given treatment protocol. Sillfurther, the processor may execute and apply certain treat protocolunits in parallel, e.g., at the same time. The user may also sharetreatment protocols and treatment protocol units with other users onother control devices by way of a network that the control deviceaccesses via its network interface 110, which may further comprisereceiving the individual treatment protocol units comprising a receivedtreatment protocol.

In one particular arrangement, the transcranial magnetic stimulationapplication program code 122 instructs the processor 112 of the controldevice 106 to assemble the treatment protocol units 120 into a treatmentprotocol to apply a treatment that implicates one or more particularmagnetic assembly devices 104. In an alternative arrangement, thetranscranial magnetic stimulation application program code 122 instructsthe processor 112 to assemble the treatment protocol units 120 into ageneral treatment program from a set of one or more treatment protocolunits 120 used to control the energization of all of the magneticassembly devices 104. In a further arrangement, the transcranialmagnetic stimulation application program code 122 instructs theprocessor 112 to generate a plurality of magnetic assembly devicespecific treatment protocols from the treatment protocol units 120, eachmagnetic assembly device specific treatment protocol to be carried outby a specific magnetic assembly device 104, and a general treatmentprotocol that is carried out by the remaining non-specified magneticassembly devices 104.

Building on the prior point, assume an exemplary treatment protocolhaving a pattern of treatment protocol units, the application of whichis directed to the magnetic assembly device positioned in proximity tothe Broca's Area of the patient. All other magnetic assembly devices usea similar treatment program, but substitute location dependent treatmentprotocol units. Since each of the treatment protocol units, whencombined in a treatment protocol, are a representation of control oroperational parameters for specific magnetic assembly devices, theprocessor executing the transcranial magnetic stimulation applicationprogram code can generate a single control signal for distribution bythe controller that details the desired rotation frequencies, durations,quintessence periods or other conditions for each of the magneticassemblies. In other words, the user can select a treatment protocol andcause the system to implement a treatment, diagnosis, mapping and so onby implementing the pattern of treatment protocol units, in parallel orserial, all based on the selection of a particular treatment protocol.

With reference now to FIG. 3, a given treatment protocol unit isrepresented as a data object which serves to provide structure to a setof data regarding a treatment protocol, such as but not limited to,rotation frequency, motor energization duration, quiescence period andspecific energizing of a particular set of zero or more magneticassembly devices. In accordance with the illustration of FIG. 3, apersistent data storage device 202, e.g., a hard disk drive, providespersistent storage for data representing discrete treatment protocolunits (“TPU”): TPU A 304, TPU B 306, TPU C 308, TPU D 310 and TPU E 312.A given treatment protocol unit 304, 306, 308, 310 and 312 provides thecontrol device with information that the processor can use to instructthe controller as to the transmission of specific electrical controlsignals to be sent to (or suppressed from) a given one of the magneticassembly devices.

A given treatment protocol unit comprises a number of data pointsregarding the instructions that the TPU represents. In accordance withthe embodiment that FIG. 3 illustrates, a given treatment protocol unitcomprises: a name or label for the TPU 326, a frequency value 314representing a rotational frequency for one or more magnetic assemblydevices, a rotational duration 316, a placement area 318 for applicationof the treatment protocol unit and a quiescence period 320. Those ofskill in the art recognize that a given TPU may identify values for lessthan all of the key-value pairs contained in a given TPU, e.g., somevalues can be null, and that the parameters represented in a given TPUcan differ from those shown in the embodiment of FIG. 3. For example,treatment protocol unit B 306 comprises an active duration or period of20 milliseconds, denoting an energized state of one or more magneticassembly devices, and a quiescence period of 34 milliseconds, denotingthe deactivation of the magnetic assembly devices during the quiescenceperiod, with a rotational frequency of 450 Hertz. Alternatively butsimilarly, treatment protocol unit C 308 provides information withrespect to rotational frequency and duration, but is silent regardingplacement and any quiescence period. Thus, a given treatment protocolunit may comprise a sequence of individual active periods interspacedwith specific quiescence sections. As will be understood, a quiescentperiod can be defined by a treatment protocol unit (“TPU”), withoutspecifying a frequency or duration or placement, as a TPU defined inthis manner can serve as a spacer between active TPUs that are combinedto define a treatment protocol.

The described TPUs can also be used to implement a Theta BurstStimulation (TBS) protocol. Here, the TBS protocol is defined as one ormore active TPUs followed by a second, quiescent TPU. In one particularimplementation, the active TPU(s) defines a three (3) pulse patterndelivered at a frequency of 50 Hz, each pulse lasting 20 ms. A quiescentTPU lasting 160 ms defines an inter-burst interval from the last burstof the present pattern to the first burst of the next pattern. Theactive and quiescent TPSs combined for a repeating treatment pattern ofhaving a duration of 200 milliseconds. While a single TPU can define amultiple burst pattern, it is also envisioned that the active TPUsdefines a single burst. Thus, a collection of single burst TPUs (eachwithout a period of quiescence following the burst) followed by a singleor collection of quiescent TPUs can also be used to define a TBSprotocol.

In one or more implementations, a treatment protocol unit can issue acommand to a single magnetic assembly device as in treatment protocolunit A. According to the operational parameters that treatment protocolunit A identifies, the protocol unit instructs that only the magneticassembly device located a “Broca's Area” is to be energized. Similarly,a given treatment protocol unit may identify a set of one or moremagnetic assembly devices on the basis of the location(s) of suchmagnetic device assembly on the cap, which energize for rotation over aperiod of time on the basis of the instructions in the given treatmentprotocol unit that the processor at the control device interprets. Inanother arrangement, the magnetic assembly device (MAD) can beaddressable on the basis of its connection point to the cap, with thelocation of the magnetic device assembly being defined as a result ofits connection to the cap by virtue of contacts on the cap. As a relatedmatter, signal feedback between the cap concerning the operationalcapabilities/status of the MADs that are attached to the cap and theirlocation of attachment can coordinate with the system so as to permittreatment protocols to be selected, and to inform the clinician orpatient that additional or different MADs have to be attached and wherethey have to be attached before a particular treatment protocol isimplemented.

As shown by way of treatment protocol unit E 212, a treatment protocolunit may comprise multiple, disparate periods or passes within atreatment protocol unit in which one or more magnetic assembly devicesare variously energized. Continuing with exemplary treatment protocolunit E 212, the treatment protocol unit comprises a first and secondenergized periods, 222 and 224, respectively, lasting 20 millisecondsand 90 milliseconds, respectively, separated by a defined quiescenceperiod that lasts for 4 milliseconds. Thus, a given treatment protocolunit may comprise complex multi-pass logic that energize one or moremagnetic assembly devices in a pattern to achieve a particular purposeor usefulness. As will be appreciated, a particular treatment protocolcan be defined by a set of one or more treatment protocol units, andinvoked by selecting that particular treatment protocol.

As described above, a given treatment protocol unit identifies one ormore particular key-value pairs that ultimately instruct a magneticassembly device as to its operational state at a given point in time.Accordingly, a given treatment protocol unit need not define eachkey-value pair contained within a given treatment protocol unit, e.g.,some keys can have a null or empty value. For example, a treatmentprotocol unit can provide information about a quintessence period freeof any energization state information, e.g., frequency and durationvalues are set to null. In such a configuration, a quiescence onlytreatment protocol unit operates as a break or spacer in the activesessions of a treatment protocol. In this way, quiescence periods can beintroduced to accompany treatment protocol units lacking a quiescenceperiod. By way of example, treatment protocol units that only define aquiescence period can be used to ensure that there is a set repetitionfrequency of between 0.1 to 2 Hertz.

A given treatment protocol unit may be implemented by the processor thatis executing transcranial magnetic stimulation application program code.Alternatively, or in conjunction with the foregoing, the transcranialmagnetic stimulation application program code may instruct the processorto implement a treatment protocol that comprises a plurality oftreatment protocol units. The transcranial magnetic stimulationapplication program code comprises program code to instruct theprocessor to present a user interface to a user or operator (e.g., aclinician) of the control device that will allow such an individual toselect one or more treatment protocol units for inclusion in a treatmentprotocol.

As shown in FIG. 4A, upon selection of one or more desired treatmentprotocol units, the transcranial magnetic stimulation applicationprogram code according to one embodiment instructs the processor toassemble the treatment protocol units into a treatment protocol 402. Aswill be understood, a treatment protocol can comprise a stored selectionof TPUs which can be selected for implementation. The transcranialmagnetic stimulation application program code instructs the processor atthe control device to assemble the individual treatment protocol units404, 406, 408, 410 and 412 into a treatment protocol 402 that issuitable for treating a specific ailment or patient, or to load fromstorage and/or otherwise implement a stored treatment protocol.According to one embodiment, the transcranial magnetic stimulationapplication program code instructs the processor to configure orassemble a set of treatment protocol units 404, 406, 408, 410 and 412according to an overall desired length of treatment. For example, if thedesired treatment is two minutes, the transcranial magnetic stimulationapplication program code instructs the processor to assemble thetreatment protocol units into a treatment protocol 402 that ensures theresulting treatment protocol is of the desired length, such as bylooping the TPUs that comprise the treatment protocol until thetreatment duration has been achieved. Alternatively, longer durationtreatment protocol units can be used in a given treatment protocol inorder to provide a treatment program of a desired length. Alternativeembodiments contemplate assembly of treatment protocol units in anad-hoc fashion to treat a desired illness or symptoms that a patient isexperiencing, such as the arrangement of treatment protocol units 416,418, 420, 422 and 424 to create the treatment protocol that FIG. 4Billustrates.

The resulting treatment protocol 402 or 414 is a data object containingdata used to instruct all or a portion of the magnetic assembly devicesto generate a specific series of electric fields within the brain of thepatient. Where different magnetic assembly devices of the same cap havedifferent treatment protocol units applied, a treatment program datasetis created, which may be saved in a persistent data store as a libraryof treatment protocols. Thus, a collection of treatment protocols aregenerated whereby different individual treatment protocols are used tocontrol one or more specific magnetic assembly devices.

With particular reference to FIG. 5, the control device executestranscranial magnetic stimulation program code implemented as acollection of submodules (each composed of program code for execution bya processor) that configure the control device to communicate with alocal or remote storage device, such as the persistent data store, RAM,ROM and network accessible data stores, to implement a transcranialmagnetic stimulation treatment protocol. Furthermore, certainembodiments implement additional program code modules and submodules,such as authentication or validation programmatic routines, which areused to access the data and provide security or other credentials priorto accessing the stored data. The processor, when executing thetranscranial magnetic stimulation program code, presents graphical userinterface controls on a display device and allows the user to create andmodify one or more of treatment protocol units, step 502. Those of skillin the art recognize that other user interfaces are applicable,including text-based “command line” interfaces. As will be appreciated,the flow diagram of FIG. 5 as well as those of FIGS. 6 and 7 areappropriate for certain clinicians and trained operators, but not for auser who is to wear the cap and undergo a treatment, diagnosis, or othersession wearing the cap 102.

Through use of the user interface controls that the control devicegenerates, a user provides a selection indicating a desire to create anew treatment protocol unit or edit an existing treatment protocol unit,step 504. The transcranial magnetic stimulation program code implementsprogrammatic logic to fork program flow on the basis of the input thatthe user provides. Accordingly, where the user instructs the controldevice to create a new treatment protocol unit, step 504, the programcode instructs the processor to display a treatment protocol unitcreation interface that allows that user to supply key-value pairsidentifying operational parameters of one or more magnetic assemblydevices for execution by the control device as a treatment protocolunit, step 506. Certain embodiments provide that a treatment protocolunit identifies multiple energized periods, which the user mayaccordingly provide as a series of one or more key-value pairs for eachperiod.

The user supplies the desired operational parameters as a set ofkey-value pairs that data acquisition routines of the transcranialmagnetic stimulation program code attempt to validate as acceptableinput, step 508. A number of thresholds may be evaluated to ensure thatthe operational parameters set by the key-value pairs not cause thedevice to operate in a manner that would be harmful to the patient, theuser or both. If the input that the user provides is invalid, step 508,the program code instructs the processor to perform a timeout check todetermine if the user has exceeded an acceptable number of attempts toprovide valid input, step 510. Where the check at steps 508 and 510 bothevaluate to false, program flow returns to step 506 with the programcode instructing the processor to display the treatment protocol unitcreation interface that allows that user to supply key-value pairsidentifying operational parameters for execution by the control deviceas a treatment protocol unit. Where the processor determines that theinput is valid, the processor opens a communication channel to thepersistent storage device and issues a write command to store the newlycreated treatment protocol unit, step 520, and the process concludes,step 512. As will be appreciated, the threshold can be preset as afunction of the treatment type (e.g., higher thresholds for depressiontreatment than, say, for mood modification).

Returning to step 504, if the user instructs the control device to editor modify an existing new treatment protocol unit, then the program codeinstructs the processor to display a listing of available treatmentprotocol units, which may be stored locally, e.g., on the persistentstorage device at the control device, or remotely for access via thenetwork interface of the control device, step 514. The user selects agiven treatment protocol unit for modification from the set of availabletreatment protocol units and the program code instructs the processor todisplay a treatment protocol unit edit interface that allows that userto edit existing or supply new key-value pairs that identify operationalparameters for execution by the control device, step 516.

The user supplies the desired operational parameters as a set ofkey-value pairs that data acquisition routines of the transcranialmagnetic stimulation program code attempt to validate as acceptableinput, step 518. A number of thresholds may be evaluated to ensure thatthe operational parameters set by the key-value pairs not cause thedevice to operate in a manner that would be harmful to the patient, theuser or both. If the input that the user provides is invalid, step 518,the program code instructs the processor to perform a timeout check todetermine if the user has exceeded an acceptable number of attempts toprovide valid input, 522. Where the check at steps 518 and 522 bothevaluate to false, program flow returns to step 516 with the programcode instructing the processor to display the treatment protocol unitedit interface that allows that user to modify existing or supply newkey-value pairs that identify operational parameters for execution bythe control device. Where the processor determines that the input isvalid, the processor opens a communication channel to the persistentstorage device and issues a write command to store the modifiedtreatment protocol unit, step 520, and the process concludes, step 512.

In addition to providing tools that allow for the creation andmodification of treatment protocol units, transcranial magneticstimulation software in accordance with embodiments of the presentinvention provides programmatic routines for the creation of treatmentprotocols consisting of a plurality of treatment protocol units.According to the embodiment set forth in FIG. 6, the process of creatinga new treatment protocol comprises accessing the control device toinstantiate and initialize the treatment protocol creation userinterface, step 602.

The treatment protocol creation user interface provides the user withcontrols to browse a set of treatment protocol units that the controldevice can maintain on local storage, remote storage, or variouscombinations thereof. Using this user interface, the user selects agiven treatment protocol unit for inclusion as part of the newly createdtreatment protocol, step 604. The program code instructs the processorto perform a check to determine if there are additional treatmentprotocol units for inclusion in the new treatment protocol, step 606.Upon receipt of feedback indicating that there are additional treatmentprotocol units for inclusion in the new treatment protocol, program flowreturns to step 604 with the user interface allowing the user to selectan additional treatment protocol unit, or similarly, remove a selectedtreatment protocol unit.

Where the user indicates that there are no additional treatment protocolunits to add to or remote from the newly created treatment protocol,step 606, the program code instructs the processor to perform a check todetermine if there is to be a modification of the order of the treatmentprotocol units selected to be part of the treatment protocol, asindicated at step 608. Where the check evaluates to true, program codeinstructs the processor to modify the treatment protocol creation userinterface so as to provide the user with controls to modify thetreatment protocol data to indicate a placement change of treatmentprotocol units within the treatment protocol, step 610. Accordingly, thecontrol device executes the treatment protocol in the modified order atruntime.

After the check at step 608 evaluates to false, thereby indicatingcompletion of any further modification to the treatment protocol data,the control device writes the treatment protocol data to a data storagedevice, step 612, which may be a persistent data storage device. Wherethe data storage device is remote from the control device, program codeinstructs the processor to open a network connection to the remote datastore for transmission and storage thereupon. The program code instructsthe processor to perform a further check to determine if there areadditional treatment protocols for creation, step 614, directing programflow back to step 604 where the check evaluates to true. Where there areno further treatment protocols that require creation, program flowterminates, step 618, and control returns from the subroutine to amaster control component of the transcranial magnetic stimulationprogram code.

FIG. 7 illustrates one embodiment of a process for modifying an existingtreatment protocol, which comprises accessing the control device toinstantiate and initialize the treatment protocol editing userinterface, step 702. The treatment protocol editing user interfaceprovides the user with controls to browse a set of treatment protocolsthat the control device may maintain on local storage, remote storage,or various combinations thereof. Using this user interface, which may bea graphical user interface, the user selects a given treatment protocolfor modification, as well as a specific treatment protocol unit formodification, step 704. The program code instructs the processor toperform a check to determine if an attempt is being made to add, modifyor delete a treatment protocol unit in accordance with the treatmentprotocol under consideration, step 706. Upon execution of the command bythe processor and recording the update to the treatment protocol unit,program flow loops through steps 704 and 706 to allow the user to add,delete or modify additional treatment protocol units that are part ofthe treatment protocol under consideration, substantially as describedabove in connection with FIG. 5. The graphical user interface that theprocessor presents under the control of the program code provides anaccess to programmatic controls that allow for execution of such controlcommands and data updates.

Where the user indicates that there are no additional treatment protocolunits to add, delete or modify from the treatment protocol, step 706,the program code instructs the processor to perform a check to determineif there is to be a modification of the order of the treatment protocolunits selected to be part of the treatment protocol. Where the checkevaluates to true, program code instructs the processor to modify thetreatment protocol creation user interface so as to provide the userwith controls to modify the treatment protocol data to indicate aplacement change or treatment protocol units within the treatmentprotocol, step 710. Accordingly, the control device executes thetreatment protocol in the modified order at runtime.

After the check at step 708 evaluates to false, thereby indicatingcompletion of any further modification to the treatment protocol data,the control device writes the treatment protocol data to a data storagedevice, step 712, which may be a persistent data storage device. Wherethe data storage device is remote from the control device, program codeinstructs the processor to open a network connection to the remote datastore for transmission and storage thereupon. The stored modifiedtreatment protocol unit can be stored as a standalone unit withoutoverwriting the TPU that was just modified, or, if the modified TPU waspart of a previously stored treatment protocol, the user can select tohave the write command store the modified treatment protocol unit aspart of a modified version of the previously stored treatment protocol,again without overwriting the treatment protocol that was just modified.

The program code instructs the processor to perform a further check todetermine if there are additional treatment protocols for editing, step714, directing program flow back to step 704 where the check evaluatesto true. Where there are no further treatment protocols that requireediting, program flow terminates, step 718, and control returns from thesubroutine to a master control component of the transcranial magneticstimulation program code.

As described throughout, the processor at the control device executesthe transcranial magnetic stimulation program code to variably energizeone (and more typically two) or more magnetic assembly devices spaced onthe cap 102 at locations that span at least a portion of the cranium ofa patient. FIG. 8 illustrates one embodiment of a method to effect suchtranscranial magnetic stimulation. The method of FIG. 8 begins with theinitialization of a transcranial magnetic stimulation subroutine that isembodied as program code deployed to the control device as part of thetranscranial magnetic stimulation program code. Execution of thesubroutine by the processor causes an attached display device to presenta stimulation specific user interface, step 802, which may be agraphical user interface or other interface suitable to conveyinformation in accordance with the various embodiments of the invention.

The control device provides programmatic tools allow for the selectionof one or more treatment protocols, step 804, e.g., through interactionwith the interface that the processor presents on the display device.The control device may provide access to treatment protocols from localstorage, as well as treatment protocols on remote data stores. Accordingto one embodiment, the control device accesses a remote data store via anetwork through use of a network interface. Upon connection to theremote data store, the control device copies the transaction protocol tolocal storage for execution by the processor. Alternatively, the controldevice accesses the remote data store and reads transaction protocolinformation as needed, e.g., remote execution of the data.

The selection of one or more treatment protocols for application to apatient, step 804, may comprise presenting a user with a listing ofavailable treatment protocols, which may also comprise a listing of theindividual treatment protocol units making up a given treatmentprotocol. Selection of a given treatment protocol can be made on thebasis of applying a treatment directed towards a particular ailment. Forexample, a drop down menu is provided in one embodiment by a graphicaluser interface that lists a set of exemplary potential ailments thatrequire treatment: depression, neurological and psychiatric disorders,migraines, aphasia, anxiety, Parkinson's disease, tinnitus, autism,schizophrenia, Alzheimer's, ALS, stroke (e.g. ischemic), MyotonicDystrophy type 1 (DM1), stuttering, epilepsy, Parkinson's disease,visceral pain and dystonia, cocaine, opioid and other addictivebehaviors. A user can select a treatment protocol (comprising one ormore treatment protocol units) that has been previously designed, andpotentially verified, to ameliorate such conditions. Alternatively, theuser is free to select one or more treatment protocol units depending onspecific conditions or circumstances, for example, one or morecollections of treatment protocol units may be presented as havingapplicability to a particular ailment, such as addiction or pain. Thedata store that maintains the treatment protocols and/or treatmentprotocol units can by associated with metadata that functions as asuggestion as to the applicability of a given treatment protocol unit ortreatment protocol.

Optionally, information can be received from a patient databaseconcerning the patient who is to wear the cap 102 over the networkinterface 110 which can define (e.g., constrain) the selection oftreatment protocols to those that correspond to a prescription by aclinician or other health care provider. Optionally, the set oftreatment protocols available for selection can be defined (e.g.,constrained) as a function of prior treatments. For instance, atreatment protocol can comprise a regimen of treatments in which theduration, energy, or other parameters are established for a patient, yetwhich vary over the course of treatment. In this way, a predefinedregimen of treatment can be implemented (and repeated with the same orother patients) with precision by virtue of providing a series oftreatment protocols through a predefined regimen.

More generally, as will be understood from the foregoing description, agiven treatment protocol comprises one or more treatment protocol units;a given treatment protocol unit contains instructions that identify theoperational parameters of one or more magnetic device assemblies thatare in communication with the control device executing software on itsprocessor to interpret such instructions. The user or an automatedsoftware process selects a given treatment protocol from a set ofavailable treatment protocols, step 804, or may select one or moretreatment protocol units for application as a treatment protocol. Inresponse to receipt of a selection of a treatment protocol, theprocessor retrieves the treatment protocol units that the treatmentprotocol identifies into memory, e.g., RAM, for execution by theprocessor that is running the transcranial magnetic stimulation programcode. According to one embodiment, the processor retrieves and loadstreatment protocol units serially for execution. Alternatively, theprocessor may retrieve multiple treatment protocol units that it loadsinto working memory for serial or dynamic execution, which depends onspecific instructions contained in the treatment protocol unit, thetranscranial magnetic stimulation program code or various combinationsthereof.

Upon receipt of a signal to begin a treatment protocol, the processorunder the control of the transcranial magnetic stimulation program coderetrieves a first treatment protocol unit for execution, step 806. Uponexecution of the treatment protocol unit, the processor issuesinstructions in accordance with the treatment protocol unit to specificmagnetic assembly devices that causes the motor or other actuator withina given magnetic assembly device to energize and induce the desiredelectrical fields within the brain of the wearer, step 808. In oneembodiment, the processor passes instructions regarding the energizingof specific magnetic assembly devices to the controller. The controllerparses or translates the treatment program into control signals oridentifies the operational parameters to implement for some or all ofthe magnetic assembly devices. For example, the controller may close aswitch that controls the magnet for a given duration and adjust apotentiometer (or its digital equivalent, e.g., a shift register) toselect a desired rotation frequency. Alternatively, the processor at thecontrol device communicates with each of the magnetic assembly devicesdirectly and passes a control signal that causes the motor(s) toenergize in accordance with instructions in a given treatment protocolunit.

According to certain embodiments, the control device is operative tomodify one or more treatment protocol units to suit the needs of apatient, in order to define a particular treatment protocol, to bringthe device within safe operating parameters, etc. Such modificationaccording to one embodiment is in response to data that the controldevices receives from one or more sensors that are deployed as part of agiven magnetic device assembly. Program code that is part of thetranscranial magnetic stimulation program code modifies the data valuesof one or more treatment protocol units, e.g., so as to alter duration,frequency or quiescence period. Similarly, such program code candynamically reorder the sequence in which the processor applies a set oftreatment protocol units, which can be based on feedback that thecontrol device receives from one or more sensors or from the patienthimself or herself. The processor executes the modified treatmentprotocol unit and or can store the modified treatment protocol unitprior or subsequent to execution. In a further implementation, based onfeedback from the user, such a modified treatment protocol unit isuploaded or transmitted back to the database for dissemination to theuser community. Furthermore, the uploaded modified treatment can beaccompanied by feedback metadata obtained from the sensors integral tothe magnetic assembly device or cap.

After execution of a treatment protocol unit by the processor, which maybe accomplished in conjunction with the controller—in addition to othersoftware and hardware components of the control device, the program codeinstructs the processor to perform a check to determine if a subsequenttreatment protocol unit requires execution, step 810. Where additionaltreatment protocol units are present that require execution by theprocessor and application to the patent, program flow returns to step806 with the processor loading a subsequent treatment protocol unit frommemory that is part of the treatment protocol that the control device isapplying to the patient. Where there are no additional treatmentprotocol units for application to the patient, the program codeinstructs the processor to determine if a subsequent treatment protocolrequires execution, step 812. Where additional treatment protocols arepresent that require execution by the processor and application to thepatent, program flow returns to step 804 whereby the user or anautomated software process selects a given treatment protocol from a setof available treatment protocols (or individual treatment protocol unitsfor application to a patient). If there are no additional treatmentprotocol units or treatment protocols that require application to thepatient, the program code instructs the processor to perform a check todetermine if the application is terminated, step 816. Applicationtermination causes the process of FIG. 8 to conclude, step 716;otherwise the application enters a wait state with the display of theapplication user interface, step 802.

While this specification contains many specific embodiment details,these should not be construed as limitations on the scope of anyembodiment or of what can be claimed, but rather as descriptions offeatures that can be specific to particular embodiments of particularembodiments. Certain features that are described in this specificationin the context of separate embodiments can also be implemented incombination in a single embodiment. Conversely, various features thatare described in the context of a single embodiment can also beimplemented in multiple embodiments separately or in any suitablesub-combination. Moreover, although features can be described above asacting in certain combinations and even initially claimed as such, oneor more features from a claimed combination can in some cases be excisedfrom the combination, and the claimed combination can be directed to asub-combination or variation of a sub-combination.

Similarly, while operations are depicted in the drawings in a particularorder, this should not be understood as requiring that such operationsbe performed in the particular order shown or in sequential order, orthat all illustrated operations be performed, to achieve desirableresults. In certain circumstances, multitasking and parallel processingcan be advantageous. Moreover, the separation of various systemcomponents in the embodiments described above should not be understoodas requiring such separation in all embodiments, and it should beunderstood that the described program components and systems cangenerally be integrated together in a single software product orpackaged into multiple software products.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention. Asused herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprises”and/or “comprising”, when used in this specification, specify thepresence of stated features, integers, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, integers, steps, operations, elements,components, and/or groups thereof.

It should be noted that use of ordinal terms such as “first,” “second,”“third,” etc., in the claims to modify a claim element does not byitself connote any priority, precedence, or order of one claim elementover another or the temporal order in which acts of a method areperformed, but are used merely as labels to distinguish one claimelement having a certain name from another element having a same name(but for use of the ordinal term) to distinguish the claim elements.Also, the phraseology and terminology used herein is for the purpose ofdescription and should not be regarded as limiting. The use of“including,” “comprising,” or “having,” “containing,” “involving,” andvariations thereof herein, is meant to encompass the items listedthereafter and equivalents thereof as well as additional items.

Particular embodiments of the subject matter described in thisspecification have been described. Other embodiments are within thescope of the following claims. For example, the actions recited in theclaims can be performed in a different order and still achieve desirableresults. As one example, the processes depicted in the accompanyingfigures do not necessarily require the particular order shown, orsequential order, to achieve desirable results. In certain embodiments,multitasking and parallel processing can be advantageous.

Publications and references to known registered marks representingvarious systems are cited throughout this application, the disclosuresof which are incorporated herein by reference. Citation of any abovepublications or documents is not intended as an admission that any ofthe foregoing is pertinent prior art, nor does it constitute anyadmission as to the contents or date of these publications or documents.All references cited herein are incorporated by reference to the sameextent as if each individual publication and references werespecifically and individually indicated to be incorporated by reference.

While the invention has been particularly shown and described withreference to a preferred embodiment thereof, it will be understood bythose skilled in the art that various changes in form and details may bemade therein without departing from the spirit and scope of theinvention. As such, the invention is not defined by the discussion thatappears above, but rather is defined by the claims that follow, therespective features recited in those points, and by equivalents of suchfeatures.

1-12. (canceled)
 13. A transcranial magnetic stimulation (“TMS”) devicefor use with a patient comprising: a head mount for disposition on ahead of a patient and configured with a plurality of attachment points;a plurality of magnetic assembly devices connected to respective ones ofthe plurality of attachment points, each magnetic assembly device beingconfigured with an actuator device to actuate a magnet and beingconfigured to receive a control signal addressed to the given magneticassembly device; and a memory; a processor configured by program codeexecuted thereby to: generate one or more treatment protocol units, byassembling a series of key-value pairs into a data structure, whereinthe data values of the data structure are used to instruct all or aportion of the magnetic assembly devices to generate a specific seriesof electric fields within the brain of the patient corresponding to oneor more operational parameters for the one or more magnetic assemblydevices, validate the generated one or more treatment protocol unitsagainst threshold value for at least one of the series of key-valuespairs; generate a control signal using at least information contained intwo or more validated generated treatment protocol units, energize atleast one of the plurality of magnetic assembly devices over a period oftime to cause the magnet to actuate according to the control signal, andmonitor a response by the patient to energizing the one or moreaddressed actuators.
 14. The TMS device of claim 13 wherein theplurality of magnetic assembly devices are permanently attached to thehead mount.
 15. The TMS device of claim 13 wherein the plurality ofmagnetic assembly devices are attached to the head mount in a releasablemanner.
 16. The TMS device of claim 13, wherein the processor isconfigured to modify at least one of the selected treatment protocolunits prior to transmission of the control signal.
 17. The TMS device ofclaim 13 wherein at least one of the data values of the generatedtreatment protocol unit indicates a period of time having a durationfrom 1-100 milliseconds and at least one other data value indicatesrepetition rate of 0.1 to 2 Hertz.
 18. The TMS device of claim 13wherein the given magnetic assembly device comprises a magnet forselectively providing a rapidly changing magnetic field of at least500-600 tesla/second corresponding to a magnet movement speed of no lessthan 400 hertz.
 19. The TMS device of claim 13 comprising one or moresensors that monitor one or more operational parameters of the givenmagnetic assembly device.
 20. The TMS device of claim 19 where the oneor more sensors are selected from the set consisting of at least atemperature sensor, a magnetometer, and an electrode.
 21. A method forproviding Transcranial Magnetic Stimulation (“TMS”) to a patient, themethod comprising: providing a head mount for disposition on a head of apatient, the head mount comprising a plurality of points for releasablemounting a plurality of magnetic device assemblies, each magnetic deviceassembly comprising a magnet and an actuator device for selectivelyproviding a rapidly changing magnetic field capable of inducing weakelectric currents in the brain of the patient so as to apply a treatmentthat modifies natural electrical activity of the brain of the patient;positioning the head mount on the head of the patient in conjunctionwith a selected number of the plurality of magnetic device assemblies onthe head mount at selected locations; generating one or more treatmentprotocol units, by assembling a series of key-value pairs into a datastructure held in the memory of a processor, wherein the data values ofthe data structure are used to instruct all or a portion of the magneticassembly devices to generate a specific series of electric fields withinthe brain of the patient corresponding to one or more operationalparameters for the one or more magnetic assembly devices; validating thegenerated one or more treatment protocol units against threshold valuefor at least one of the series of key-values pairs; assembling two ormore validated treatment protocol units into a treatment protocol forexecution by the programmable processor, the programmable processoroperative to generate a control signal utilizing the two or morevalidated treatment protocol units; and providing a rapidly changingmagnetic field with at least one of the magnet assemblies in accordancewith the treatment protocol and in response to receipt of the controlsignal.
 22. The TMS method of claim 21 comprising modifying at least onegenerated treatment protocol units upon a determination that thegenerated treatment protocol unit is invalid.
 23. The TMS method ofclaim 21, wherein the treatment is selected from depression,neurological and psychiatric disorders, migraines, aphasia, anxiety,Parkinson's disease, tinnitus, autism, schizophrenia, Alzheimer's, ALS,stroke (e.g. ischemic), Myotonic Dystrophy type 1 (DM1), stuttering,epilepsy, Parkinson's disease, visceral pain and dystonia, cocaine,opioid and other addictive behavior.
 24. A transcranial magneticstimulation (“TMS”) system comprising: a plurality of magnetic assemblydevices for deployment around the cranium of a patient, each of theplurality of magnetic assembly device configured with at least onemagnet and each of the plurality of magnetic assembly device isconfigured to rotate the magnet at one of a specific frequency orfrequencies in response to the receipt of a control signal addressed toat least one of the plurality of magnetic assembly devices and monitor,through one or more sensors, one or more operational parametersassociated with the magnetic assembly device; and a processor incommunication with a memory and configured by program code executingthereon to: generate one or more treatment protocol units, by assemblinga series of key-value pairs into a data structure, wherein the datavalues of the data structure are used to instruct all or a portion ofthe magnetic assembly devices to generate a specific series of electricfields within the brain of the patient corresponding to one or moreoperational parameters for the one or more magnetic assembly deviceswherein a given generated treatment protocol unit identifies datacorresponding to at least a rotational frequency, validate the generatedone or more treatment protocol units against threshold value for atleast one of the series of key-values pairs, generate a control signalusing at least information contained in at least two generated treatmentprotocol units, energize at least one of the plurality of magneticassembly devices over a period of time to cause the magnet to actuateaccording to the control signal, and monitor the patient in response toenergizing to addressable actuator.
 25. The TMS device of claim 13,wherein the control signal is generated by assembling the generatedtreatment protocol units in order to provide the treatment protocol. 26.The TMS device of claim 13, wherein the processor is further configuredby program code to assemble the treatment protocol units according to anoverall length of treatment.
 27. The TMS device of claim 26, wherein theprocessor is configured by program code to loop the treatment protocolunits that comprise the treatment protocol to provide the overall lengthof treatment.
 28. The TMS device of claim 26, wherein the processor isconfigured by program code to use longer duration treatment protocolunits that comprise the treatment protocol to provide the overall lengthof treatment.
 29. The TMS device of claim 25, wherein the treatmentprotocol comprises a data object containing data used to instruct all ora portion of the magnetic assembly devices to generate a specific seriesof electric fields within the brain of the patient.
 30. The TMS methodof claim 25, wherein the treatment protocol comprises a data objectcontaining data used to instruct all or a portion of the magneticassembly devices to generate a specific series of electric fields withinthe brain of the patient, and wherein the control signal is received byretrieval of the data object from a persistent data storage device. 31.The TMS system of claim 24, wherein the control signal is generated byassembling the retrieved treatment protocol units in order to providethe at least one treatment protocol.